Avalign
Wylie Renal Vein Retractor
3manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | FGN |
| Device type | Retractor, Non-Self-Retaining |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-03 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM29-3182 | In distribution | |
| VM29-3183 | In distribution | |
| VM59-2417 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 408 |
| Omni-Tract® | Integra Lifesciences Corporation | 252 |
| Orthomed | Ortho-MED, Inc. | 205 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 47 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 26 |
| V. Mueller | Steris Corporation | 24 |
| Novo Surgical | Novo Surgical, Inc. | 24 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 18 |
| Ambler Surgical | Ambler Surgical, LLC | 16 |
| Tebbetts Suction Wound Retractor | Sontec Instruments, Inc. | 12 |
| Cochran Pediatric Retractor | Sontec Instruments, Inc. | 10 |
| Pilling | Teleflex Medical LLC | 10 |
Showing 12 of 51. All products under Retractor, Non-Self-Retaining
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.